Identity
- Trade Name
- QUANTA Lite® MPO IgG ELISA FDA UDI
- Generic Name
- Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, reagent FDA UDI
- Device Name
- 1. 1x MPO IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted MPO IgG ELISA Low Positive 4. 1x 1.2mL prediluted MPO IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
- Model / Reference
- 708700 FDA UDI
- Description
- 1. 1x MPO IgG ELISA microwell plate (12-1 x 8 wells), with holder 2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted MPO IgG ELISA Low Positive 4. 1x 1.2mL prediluted MPO IgG ELISA High Positive 5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate 7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG 8. 1x 10mL TMB Chromogen 9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950448280 FDA UDI
- 510(k) Number
- K981330 FDA UDI
- FDA Product Code
- MOB FDA UDI
- GMDN Term
- Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, reagent
QUANTA Lite® MPO IgG ELISA by Inova Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA).
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- AESKULISA® MPO — Aesku.Diagnostics GmbH & Co. KG · Class II
- Myeloperoxidase IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- IMMCO DIAGNOSTICS — Immco Diagnostics, Inc. · Class II
- Anti-MPO ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AG · Class II
- WIESLAB Capture MPO-ANCA — Euro-Diagnostica AB · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (1)
- FDA UDI 647103bf-30fe-4921-85e6-623bbe8724f7 36 fields · synced May 30, 2026